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FDA Warns of Risk of Heart Attack, Death With Cardiac Stress-Test Drugs

Agency updates labels for regadenoson and adenosine (November 20)

The FDA is warning health care professionals of the rare but serious risk of heart attack and death with the use of the cardiac nuclear stress-test agents regadenoson (Lexiscan) and adenosine (Adenoscan), both manufactured by Astellas Pharma. The agency has approved changes to the drugs’ labels to reflect these serious events and has updated its recommendations for the use of these agents. Health care professionals should avoid using these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions.

Regadenoson and adenosine are FDA-approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately. Both agents help identify coronary artery disease by dilating the arteries of the heart and by increasing blood flow to help identify blocks or obstructions in the heart’s arteries. Regadenoson and adenosine cause blood to flow preferentially to the healthier, unblocked or unobstructed arteries, which can reduce blood flow in the obstructed artery. In some cases, this reduced blood flow can lead to a heart attack, which can be fatal, according to the FDA.

The “Warnings and Precautions” section of the regadenoson and adenosine labels previously contained information about the possible risk of heart attack and death with the use of these drugs. However, recent reports of serious adverse events in the FDA Adverse Event Reporting System (FAERS) database and in the medical literature prompted the agency to approve changes to the drug labels to include updated recommendations for use. Some events occurred in patients with signs or symptoms of acute myocardial ischemia, such as unstable angina or cardiovascular instability.

Cardiac resuscitation equipment and trained staff should be available before administering regadenoson or adenosine, the FDA says. At this time, data limitations prevent the agency from determining whether there is a difference in the risk of heart attack or death between the two agents.

Source: FDA; November 20, 2013.

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